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Valcamp

Valcamp

amlodipine + valsartan

Manufacturer:

Sandoz

Distributor:

Sandoz
Concise Prescribing Info
Contents
Per 5 mg/80 mg FC tab Amlodipine besilate 5 mg, valsartan 80 mg. Per 5 mg/160 mg FC tab Amlodipine besilate 5 mg, valsartan 160 mg. Per 10 mg/160 mg FC tab Amlodipine besilate 10 mg, valsartan 160 mg
Dosage/Direction for Use
1 tab daily. Initially 5 mg/80 mg once daily, may be increased to a max of one 10 mg/320 mg tab once daily after 1-2 wk. Elderly & patient w/ hepatic impairment Consider starting at the lowest available dose of amlodipine (5 mg).
Administration
May be taken with or without food: Take w/ some water.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in patients w/ type 2 DM. Pregnancy.
Special Precautions
Not recommended as initial therapy in patients w/ intravascular vol depletion. Risk of symptomatic hypotension in patients w/ activated renin-angiotensin system (RAS) (eg, vol- &/or Na-depleted patients receiving high doses of diuretics). Risk of hyperkalemia. Discontinue immediately in patients who develop angioedema. Always include assessment of renal function in evaluation of patients w/ heart failure or post MI. Risk of worsening angina pectoris & acute MI after starting or increasing dose of amlodipine, particularly in patients w/ severe obstructive CAD. Dual blockade of RAS w/ other agents blocking RAS eg, ACE inhibitors or aliskiren. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Patients w/ unilateral or bilateral renal artery stenosis, stenosis to solitary kidney; serious CHF (NYHA III-IV); aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy; severe renal impairment (CrCl <10 mL/min); recent kidney transplantation; hepatic impairment or biliary obstructive disorders. Not to be used during pregnancy & in women planning to become pregnant. Not advisable during lactation. Not recommended in ped patients <18 yr.
Adverse Reactions
Nasopharyngitis, flu; headache; edema, pitting edema, facial edema, peripheral edema, fatigue, flushing, asthenia, hot flush.
Drug Interactions
Amlodipine: Increased systemic exposure of simvastatin. Increase in systemic exposure w/ diltiazem (CYP3A4 inhibitor). Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Exposure may be increased w/ grapefruit juice. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ dual blockade of RAS w/ ARBs, ACE inhibitors, or aliskiren. Increased K levels w/ K supplements, K-sparing diuretics, salt substitutes containing K, or other drugs that may increase K levels (heparin). Attenuation of antihypertensive effect & increased risk of worsening of renal function w/ NSAIDs including selective COX-2 inhibitors. Increased serum lithium conc & toxicity. Increased systemic exposure w/ inhibitors of OATP1B1 (rifampin, ciclosporin) or MRP2 (ritonavir).
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
C09DB01 - valsartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Valcamp 10 mg/160 mg FC tab
Packing/Price
7's
Form
Valcamp 5 mg/160 mg FC tab
Packing/Price
7's
Form
Valcamp 5 mg/80 mg FC tab
Packing/Price
7's
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